Breast Cancer
Conditions
Brief summary
This is a single arm, modified dose escalation, open label trial with the objectives of: (1) Determining a safe optimal dose of INCB007839 in combination with trastuzumab and docetaxel (2) Determining clinical efficacy and safety of INCB007839 in combination with trastuzumab and docetaxel.
Interventions
DRUGINCB007839
100 mg BID
DRUGtrastuzumab
trastuzumab will be administered at a loading dose of 8 mg/kg as a 90 minute intravenous infusion on Day 8. In all subsequent 21-day cycles, trastuzumab will be administered at 6 mg/kg as a 90 minute intravenous infusion on Day 1.
DRUGDocetaxel
Sponsors
Incyte Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed metastatic breast carcinoma that is HER2 positive * Measurable disease as defined by the RECIST criteria * Life expectancy greater than or equal to 6 months * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion criteria
* Received any anticancer medications in the 28 days prior to enrollment into this study * Received any anticancer medications for cancers other than breast cancer within 6 months prior to enrollment in this study. * History of deep venous thrombosis within the last year * Contraindication to low dose warfarin therapy * Clinically significant cardiomyopathy * Prior treatment with INCB007839 or trastuzumab or lapatinib
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (complete + partial response) using RECIST (Response Evaluation Criteria in Solid Tumor) criteria | Day 1 of each completed subsequent 21-day treatment cycle and the End of Study Visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To determine the plasma pharmacokinetic (PK) profile of INCB007839 and trastuzumab when given in combination | Monthly | For Cycle 1, PK samples to be collected on Day 8 and Day 15 at pre-dose the morning dose of INCB007839. For Cycles 2, 3 and 4, PK will be collected as a single sample, obtained at pre-dose, on Day 1. PK samples will not be collected at Cycle 5 or later. o. For Cycle 1, PD samples to be collected at time of screening and at pre-dose on Day 1, Day |
Countries
India
Outcome results
None listed